Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT05798767
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2023-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Cognitive Impairment Predicts Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-03-22', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delirium', 'timeFrame': 'February 2022 to March 2023', 'description': 'postoperative delirium accessed by the Short Confusion Assessment Method (CAM)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium in Old Age', 'Neurocognitive Disorders', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '37545595', 'type': 'DERIVED', 'citation': 'Li F, Miao M, Li N, Zhou J, Sun M, Zhang J. Prevalence of preoperative cognitive impairment among elderly thoracic surgery patients and association with postoperative delirium: a prospective observational study. Front Hum Neurosci. 2023 Jul 20;17:1234018. doi: 10.3389/fnhum.2023.1234018. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Preoperative cognitive impairment (PCI) may increase the incidence of postoperative delirium (POD), yet screening for cognitive impairment is rarely performed. This study hypothesized that Mini-Cog for preoperative cognitive impairment screening predicts postoperative delirium. Elderly patients (65 years or older) attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery were recruited into the study.", 'detailedDescription': 'We collected data points on demographics and hospital episodes through the electronic medical record the day before surgery. Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed, and the time spent on Mini-Cog test and MMSE assessment was recorded. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Elderly patients attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 65 years of age or older,\n2. elective thoracic surgery,\n3. under general anesthesia.\n\nExclusion Criteria:\n\n1. history of psychiatric disorders,\n2. use of any antipsychotic drugs,\n3. ASA score \\>3\n4. severe visual, hearing, or physical dysfunction unable to complete the scale\n5. advanced malignant tumors of the chest with distant metastases to bone, liver, etc.,\n6. history of general anesthesia surgery in the last six months.'}, 'identificationModule': {'nctId': 'NCT05798767', 'briefTitle': 'Preoperative Cognitive Impairment Predicts Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'Preoperative Cognitive Impairment Predicts Postoperative Delirium in Elderly Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'PCI and POD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCI group', 'description': 'Patients with a Mini-Cog score of 3 or less were in the PCI group', 'interventionNames': ['Behavioral: Neuropsychological tests']}, {'label': 'Normal group', 'description': 'Patients with a Mini-Cog score of 3 or 4 were in the normal group', 'interventionNames': ['Behavioral: Neuropsychological tests']}], 'interventions': [{'name': 'Neuropsychological tests', 'type': 'BEHAVIORAL', 'description': 'Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed the day before surgery.\n\nThe Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium.', 'armGroupLabels': ['Normal group', 'PCI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'country': 'China', 'facility': "Henan People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}